Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BX-500 ELECTRONIC MUSCLE EXERCISER

K-Number: K822287 · 1982-10-13

ApplicantBloomex International, Inc.
Decision Date1982-10-13
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BX-500 ELECTRONIC MUSCLE EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Bloomex International, Inc.. It received FDA 510(k) clearance on 1982-10-13 under 510(k) number K822287. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BX-500 ELECTRONIC MUSCLE EXERCISER?

BX-500 ELECTRONIC MUSCLE EXERCISER is a medical device that received FDA 510(k) clearance on 1982-10-13. The listed applicant is Bloomex International, Inc.. The 510(k) number is K822287.

When did BX-500 ELECTRONIC MUSCLE EXERCISER receive FDA 510(k) clearance?

BX-500 ELECTRONIC MUSCLE EXERCISER received FDA 510(k) clearance on 1982-10-13, under 510(k) number K822287.

Who is the listed applicant for BX-500 ELECTRONIC MUSCLE EXERCISER?

The FDA 510(k) record lists Bloomex International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BX-500 ELECTRONIC MUSCLE EXERCISER?

The FDA product code for BX-500 ELECTRONIC MUSCLE EXERCISER is IPF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bloomex International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942195BX-400SK943185BX-200 SCK842142BX-400K841779ELECTRONIC MUSCLE EXERCISE EQUIPMENTK832976BX-600 EMSK821110ELECTRONIC MUSCLE EXERCISER

View all 16 devices →

Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑